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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problems Material Deformation (2976); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2023
Event Type  malfunction  
Event Description
It was reported that after fluid dosing the needle was not able to remove.It was further reported that the needle was bent, and the safety mechanism was not activated.It is unknown when the needle bend happened.There was no reported patient injury.No other information was provided.
 
Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The manufacturer has received the sample and is pending evaluation.Results are expected soon.
 
Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of a bent needle was confirmed.The product returned for evaluation was a one 22 ga x 0.75 in safestep infusion set.The returned product sample was evaluated and the needle was observed to be bent at the needle shaft the following observations were noted during the sample evaluation: usage residue was seen on the sample which proved that the product had experienced at least some use the bend in the needle had occurred away from the needle base which can be caused by device manipulation during/following port access.The needle tip was barbed suggesting contact between the needle and port base.An attempt to advance the safety over the needle tip was successful; however, additional effort was required to advance the safety sleeve past the bent region of the needle.Force applied at an angle to the needle axis, or if the needle is not inserted perpendicular into the port septum, can lead to bending of the needle shaft.It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or port may be damaged at insertion.Additionally, avoid excessive manipulation once the needle is in the port.No potential damage related to the manufacturing process was noted on the complaint sample.H3 other text : evaluation findings are in section h.11.
 
Event Description
It was reported that after fluid dosing the needle was not able to remove.It was further reported that the needle was bent, and the safety mechanism was not activated.It is unknown when the needle bend happened.There was no reported patient injury.No other information was provided.
 
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Brand Name
SAFESTEP HUBER NEEDLE SET 22G X 0.75IN
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer Contact
kayla bevins
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key16865609
MDR Text Key314529379
Report Number3006260740-2023-01688
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741066160
UDI-Public(01)00801741066160
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberLH-0029
Device Lot NumberASGRF021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/13/2023
Initial Date FDA Received05/03/2023
Supplement Dates Manufacturer Received05/15/2023
Supplement Dates FDA Received05/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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